FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
31513–31536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2016
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K153045 · BXN
Easy Med Instrument Co., Ltd.
Anesthesiology · 207d
Cleared May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix...
K153236 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 186d
Cleared May 13, 2016
DD medical polymers
K153490 · EBG
Dental Direkt GmbH
Dental · 161d
Cleared May 13, 2016
AirFit F20
K153563 · BZD
Resmed, Ltd.
Anesthesiology · 151d
Cleared May 13, 2016
ArcCHECK-MR
K160057 · IYE
Sun Nuclear Corporation
Radiology · 122d
Cleared May 13, 2016
ALTA Anterior Cervical Interbody Spacer
K160154 · ODP
Astura Medical
Orthopedic · 114d
Cleared May 13, 2016
Perimeter Otis™ 1.0 Optical Coherence Tomography System
K160240 · NQQ
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 102d
Cleared May 13, 2016
LT-300 HD
K160380 · HEX
Lutech Industries, Inc.
Obstetrics & Gynecology · 93d
Cleared May 13, 2016
Oasis Lacrimal Intubation Set
K160710 · OKS
Anodyne
Ophthalmic · 59d
Cleared May 13, 2016
Diagnostic Imaging Color LCD Monitor
K161057 · PGY
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared May 13, 2016
EzDent-i / E2 / Prora View
K161117 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared May 13, 2016
SonoSite iViz Ultrasound System
K161119 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 23d
Cleared May 12, 2016
Venous Assist System
K150980 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 394d
Cleared May 12, 2016
VERIFY STEAM Integrating Indicator
K152630 · JOJ
STERIS Corporation
General Hospital · 240d
Cleared May 12, 2016
ReNew Sterilization Trays(Catalog #3708 and #3709)
K152745 · KCT
Microline Surgical, Inc.
General Hospital · 232d
Cleared May 12, 2016
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution...
K152749 · DPT
Moor Instruments, Ltd.
Cardiovascular · 232d
Cleared May 12, 2016
LSFG-NAVI
K153239 · HKI
Softcare Co., Ltd.
Ophthalmic · 185d
Cleared May 12, 2016
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile...
K153316 · KGO
Cardinal Health, Inc.
General Hospital · 177d
Cleared May 12, 2016
Genteel Lancing Device
K153670 · FMK
Genteel, LLC
General & Plastic Surgery · 143d
Cleared May 12, 2016
Guiding Catheter
K153703 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 141d
Cleared May 12, 2016
GORE DrySeal Flex Introducer Sheath
K160254 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 101d
Cleared May 12, 2016
Monoject Enteral Feeding Syringe with ENFit Connector
K160419 · PNR
Covidien
Gastroenterology & Urology · 86d
Cleared May 12, 2016
Laser Helmet LH40-EVO
K161046 · OAP
Theradome, Inc.
General & Plastic Surgery · 29d
Cleared May 11, 2016
Slit Lamp Microscope
K152429 · HJO
Shanghai Mediworks Precision...
Ophthalmic · 259d